FDA grants Priority Review to Supplemental NDA for Revuforj® (revumenib) in R/R mNPM1 AML; PDUFA action date Oct 2025 July 1, 2025
First Patient Completes DLT Observation Period with No Reported DLTs in Ph 1 Trial of CER-1236 June 24, 2025
FDA Accepts and grants Priority Review of NDA for Ziftomenib in Adults with R/R NPM1-Mutant AML June 3, 2025
EMA approves CTA to conduct pivotal Ph 2B/3 trial of Annamycin + cytarabine in R/R AML patients May 21, 2025
Tuspetinib-based Triplet regimen in 1L AML Patients in Ph 1/2 TUSCANY Trial Demonstrates Safety, Complete Remissions May 6, 2025
Innate Pharma regains rights on CD123 targeting ANKET® and announces Sanofi’s intention to make a strategic investment in the Company April 30, 2025
Sarah Cannon Research Institute at Colorado Blood Cancer Institute Announced as Key Clinical Trial Site for Ph 1 Trial of CER-1236 in AML April 30, 2025
NDA submitted to the US FDA for ziftomenib in adult patients with R/R AML with NPM 1 mutation April 16, 2025